Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety of a novel adjuvanted hbv vaccine in healthy volunteers positive for the hla-dq2 genotype

Conditions: Hepatitis B

Summary: this study compares the immunogenicity and safety of the novel adjuvanted hbv vaccine and engerix™-b administered to subjects who were positively identified as having the hla-dq2 genotype

at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham

Eligibility criteria:
inclusion criteria: * a male or female ≥ 15 years of age at the time of the first vaccination. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * written informed consent obtained from the subject/ from the parents or guardians of the subject. * known to be seronegative for anti-hbs-antibodies, anti-hbc-antibodies and/or hbsag. * positive for the hla-dq2 genotype as determined in the previous sero-hbv-069 prevalence study. * if the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine. * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after. * previous vaccination against hepatitis b. * history of non-response to previous hepatitis b vaccination. * known exposure to hepatitis b within 6 weeks. * history of hepatitis b infection. * confirmed human immunodeficiency virus (hiv) infection. * a family history of congenital or hereditary immunodeficiency. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute disease at the time of enrollment. * hepatomegaly, right upper quadrant abdominal pain or tenderness. * administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period. * pregnant or lactating female

Keywords: recombinant hepatitis b vaccine adjuvanted hepatitis b vaccine hepatitis b
dysphagia in intermediate care units

Conditions: Dysphagia

Summary: retrospective study in intermediate care unit patients on the incidence, risk factors, and effects on mortality of dysphagia. during a 6-month observational period, routine data will be collected and analysed.


Eligibility criteria:
inclusion criteria: * intermediate care unit patients admitted within the observational period exclusion criteria: * documented refusal to general consent
effectiveness and adherence of golimumab in rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: this will be a prospective, observational, single-arm, registry study based on data received from chinese registry of rheumatoid arthritis (credit) database to register 200 chinese ra patients treated with golimumab in one year. patient characteristic, clinical effectiveness and drug adherence of golimumab will be evaluated.

this multicenter (12 centers), prospective program will register 200 ra patients routinely receiving golimumab treatment. doctor will record the disease evaluation, concomitant drug, adverse events and laboratory tests based on patient's visit till they withdraw from clinical visit. doctor will still collect above information whether patient interrupt or stop golimumab till the end of program or patient withdraw permanently.

Eligibility criteria:
inclusion criteria: * - 18 years and older * fulfil the acr/eular classification criteria for ra in 2010 * patients able to understand and complete self-evaluation questionnaires. exclusion criteria: * - contraindications for golimumab * prior exposure to tnfi/jaki
a study of pro95780 in combination with rituximab in patients with non-hodgkin's lymphoma that has progressed following previous rituximab therapy (apm4083g)

Conditions: Non-Hodgkin's Lymphoma

Summary: this phase ii, single-arm, open-label, multicenter trial is designed to evaluate the safety, efficacy, and pharmacokinetics of pro95780 when combined with rituximab in patients with follicular, cd20-positive b-cell nhl that has progressed following previous rituximab therapy.


Eligibility criteria:
inclusion criteria: * signed informed consent form * age ≥ 18 years * diagnosis of follicular, cd20-positive b-cell nhl * progression of disease after an objective response or stable disease lasting \> 6 months following completion of the most recent rituximab-containing regimen * measurable disease * life expectancy of \> 3 months exclusion criteria: * grade 3b follicular lymphoma (according to the who classification) or histologic transformation from follicular lymphoma to aggressive lymphoma * prior radiotherapy to a lesion(s) that will be used to assess response unless that lesion(s) shows clear evidence of lymphoma progression at baseline * radiotherapy to a peripheral lesion within 14 days prior to cycle 1, day 1 or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to cycle 1, day 1 * concurrent systemic corticosteroid therapy * other invasive malignancies within 3 years prior to first study drug administration except for adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, in situ breast cancer, in situ prostate cancer, limited-stage bladder cancer, or other cancers from which the patient has been disease-free for at least 3 years. * history or evidence on physical examination of central nervous system (cns) disease * prior treatment with agonistic dr4 or dr5 antibodies or apo2l/trail

Keywords: nhl rituxan lymphoma cd20-positive b-cell apm4083g
functional magnetic resonance imaging in patients with obstructive sleep apnea syndrome

Conditions: Obstructive Sleep Apnea Syndrome

Summary: the obstructive sleep apnea syndrome (osas) involves recurrent sleep-related upper airways (ua) collapse. ua mechanical properties and neural control are altered, imposing a mechanical load on inspiration. ua collapse does not occur during wakefulness, hence arousal-dependent compensation. experimental inspiratory loading in normal subjects elicits respiratory-related cortical activity during wakefulness. the objective of this study is to test whether awake osas patients would exhibit a similar cortical activity. whether or not such cortical compensatory mechanisms have cognitive consequences would be also analyze.


Eligibility criteria:
inclusion criteria : 1. osas patients * severe osas with an apnea-hypopnea index (ahi) \> 30/h * without cpap treatment 2. non-osas patients * absence of osas (ahi \< 15/h and absence of excessive daytime sleepiness with epworth score \<11) non-inclusion criteria : * \< 18 years old * \>75 years old * left-handed * bmi\> 40 kg/m² * another sleep disorder * central component of sleep apnea syndrome (central apnea index\> 5 / h) * current or past neurological pathology * respiratory pathology (obstructive ventilatory disorder, restrictive ventilatory disorder, hypercapnia) * mri contraindication (metallic foreign body, claustrophobia, pregnant woman, etc.) * taking drugs that can modify the bold signal on mri (psychotropic drugs, vasodilators, vasoconstrictors, etc.), * uncorrected sensory impairment (vision or hearing) * protected by law. exclusion criteria : * pregnant woman according to the positive beta-hcg test result * left-handed following the laterality questionnaire * mini results showing: * a current mood episode * a current disorder of the use of psychoactive substances or in the last 6 months (excluding tobacco) * an eating disorder * a diagnosis of bipolar disorder, current or past schizophrenia
behavioral relaxation approaches for insomnia in lung cancer patients

Conditions: Insomnia

Summary: this is a randomized, 30-day research study that is exploring the effects of two simplified mindfulness interventions in lung cancer patients aimed to improve their sleep quality and anxiety regarding sleep. the investigators will be enrolling a total of 20 patients who have insomnia symptoms. patients will use a behavioral intervention to help with their sleep.

the objective is to implement and examine the outcomes of a simplified relaxation intervention, assisted relaxation therapy (art), for lung cancer patients who experience insomnia symptoms and other sleep difficulties. this intervention includes using a smartphone application. a variety of surveys will be used to track the interventions' efficacy throughout the study. to test these interventions, the investigators will recruit participants (n=20) from a weekly oncology patient list located within the university of pennsylvania. participants with a history of lung cancer who are recruited into the study must have a smartphone. participants will use the art intervention over the course of 2 weeks and will receive surveys at enrollment (d0), end of intervention (d14) and 2 weeks post-intervention (d30). missing data will be handled using imputation methods. the investigators will analyze the data using statistical programs to determine progress throughout the study.

Eligibility criteria:
inclusion criteria: * 18 or older * diagnosed with lung cancer (in remission, undergoing immune modulated chemotherapy, undergoing platinum-based chemotherapy * fluent in english * has access to smartphone * has internet connection at home * more than 4 weeks post-surgery exclusion criteria: * inability to speak english or communicate verbally * medical or other factors that, in the opinion of the study research team, would interfere with their ability to participate in the intervention (such as inability to participate in the guided compassion training due to deafness)

Keywords: lung cancer
advair diskus® (fluticasone propionate/salmeterol) inhaler versus serevent diskus® (salmeterol) inhlaer on inflammatory cells and markers in chronic obstructive pulmonary disease. advair diskus® and serevent diskus® inhalers are trademarks of the gsk group of companies.

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study evaluates the effect of two medicines on copd (chronic obstructive pulmonary disease). the study will last 12 weeks. at the end of 12 weeks of treatment, subjects will stop the study medicines for 2 weeks. the study will involve 6 visits to the clinic. subjects who elect to undergo bronchoalveolar lavage (bal) procedures will have 8 study visits. subjects will give sputum, blood, and in some cases bal samples. subjects will have breathing tests and will complete diary cards during the study. all study medicines and examinations will be given at no cost to the study subjects. both medicines used in this study have been approved by the us fda.


Eligibility criteria:
inclusion criteria: * diagnosis of copd. * pre-bronchodilator fev1 less than or equal to 70.0% and greater than or equal to 0.70l * ex-smokers with at least a 10 pack-year history. exclusion criteria: * current of secondary diagnosis of asthma or current diagnosis of atopy. * other respiratory disorders other than copd. * other inflammatory diseases. * abnormal and clinically significant chest x-ray or ecg. * lung resection surgery within past 1 year. * history of cancer not in remission within past 2 years. * serious, uncontrolled disease. * pregnancy or planning to become pregnant during the study.

Keywords: inflammation fev1 sputum
mother and late preterm lactation study

Conditions: Breastfeeding; Postnatal Depression; Stress, Psychological; Preterm Infant

Summary: breastfeeding has various benefits for the mother and infant. it has the capability of reducing the risk of short term and long term problems for the infant, such as gastroenteritis, respiratory infections, type ii diabetes and obesity, and of providing benefits for neurodevelopment. breast milk offers even greater benefits for preterm infants. some of the advantages of breastfeeding are related to the constituents of breast milk such as the macronutrients and bioactive factors, the hormones associated with breastfeeding such as oxytocin, and the behavioural aspects of breastfeeding (maternal sensitivity to infant cues). despite these advantages, breastfeeding rates are below target levels mainly due to the challenges that women face that hinder breastfeeding success. interventions aimed at improving policies, practices, and maternal support have been developed. however, other interventions that target specific modifiable barriers to breastfeeding can be useful. the aim of this study is to investigate a simple support intervention for breastfeeding mothers of late preterm and early term infants on maternal stress reduction and infant weight gain. the investigators also aim to study the potential mechanisms by which this effect could be achieved (breast milk composition and volume, mother and infant behaviour).


Eligibility criteria:
inclusion criteria: * mothers of late preterm infants (34 to \<37 weeks) or early term infants (37 to 38 weeks) * intending to breastfeed for at least 6 weeks * free from serious illness * fluent in english exclusion criteria: * currently smoking or intending to smoke while breastfeeding * not based in london * prior breast surgery

Keywords: breastfeeding postnatal mental health breastfeeding support stress late preterm infant breast milk
rise (rehabilitation intervention for people with schizophrenia in ethiopia)

Conditions: Schizophrenia Spectrum Disorder; Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Summary: the purpose of this study is to determine whether community-based rehabilitation plus facility-based care is superior to facility-based care alone in reducing disability related to schizophrenia in rural ethiopia.

this is a cluster randomised trial set in rural ethiopia with kebeles (villages) as the unit of randomisation. 54 kebeles will be included. 27 will be randomly allocated to the intervention arm (facility based care (fbc) + community-based rehabilitation (cbr)) and 27 randomly allocated to the control arm (fbc alone). the aim is to determine whether cbr + fbc is superior to fbc alone in reducing disability related to schizophrenia, measured by the who disability assessment schedule version 2.0 (whodas 2.0) at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * age ≥18 years * diagnosis of schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder or schizophreniform disorder) using (dsm-iv) criteria * evidence of severe, enduring or disabling illness * resident in kebele for \>6 months and no immediate plans to leave the kebele * has a primary caregiver who is willing to participate in the study exclusion criteria: * no specific criteria

Keywords: schizophrenia psychotic disorders schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder or schizophreniform disorder) using dsm-iv criteria
homeopathic treatment of post-acute covid-19 syndrome

Conditions: Post-acute Covid-19 Syndrome

Summary: to determine whether an individually prescribed homeopathic medicine has an effect greater than a placebo and is a viable treatment option to improve fatigue and quality of life for patients suffering from the symptoms of post-acute covid-19 syndrome. the researchers hope to achieve this goal by conducting a clinical trial that is scientifically rigorous and clinically relevant. expected results of this pilot study will be to obtain sufficient experience and preliminary feasibility data to justify a larger clinical trial of this hypothesis.

the researchers objectives for the study are to: 1) identify efficient means of recruiting subjects, 2) test and refine the initial study design and treatment protocol, 3) evaluate the instruments for assessing treatment outcomes, 4) estimate sample sizes that will be required in the full-scale trial, 5) determine which homeopathic medicines are most often prescribed for this syndrome, and 6) determine whether there is a measurable effect size difference or positive trend in reduction of symptoms in patients treated with homeopathy.

Eligibility criteria:
inclusion criteria: * ages 18-64 * any ethnicity * adequate cognitive function to be able to give informed consent * technologically competent to complete web forms and perform video calls * positive pcr test (polymerase chain reaction) result for sars-cov-2 (severe acute respiratory syndrome coronavirus 2) * persistent fatigue for a minimum of 60 days since diagnosis of covid-19. * a fatigue score above 21 in the fatigue assessment scale upon enrollment * willing to fill out regular questionnaires * willing to use homeopathic medicines exclusion criteria: * clinically significant kidney, heart, or hepatic impairment as determined by clinical judgment * previous hospitalization in icu for covid-19 * diagnosis of chronic fatigue syndrome, fibromyalgia, or lyme disease prior to covid-19 * chronic psychiatric illness or neurological illness prior to covid-19 diagnosis taking opioid analgesics, opioid dependence or undergoing treatment for substance abuse or addiction * taking steroid medication or immunosuppressive medications * suspected or confirmed pregnancy or breastfeeding * active cancers * current treatment by a homeopathic practitioner * initiation of another treatment for long covid within the past 2 months

Keywords: long covid
safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising oral doses of bi 1021958 in otherwise healthy controlled asthmatic subjects

Conditions: Healthy; Asthma

Summary: to investigate safety, tolerability, pharmacokinetics including posology, and pharmacodynamics of multiple rising doses of bi 1021958 in otherwise healthy mild asthmatic subjects


Eligibility criteria:
inclusion criteria: 1. healthy male and female subjects ofn non child-bearing potential exclusion criteria: 1. any relevant deviation from healthy conditions except mild controlled asthma
evaluation of a decision aid for adult cystic fibrosis patients considering bilateral lung transplantation

Conditions: Cystic Fibrosis

Summary: in 2006, the international patient decision aids collaboration (ipdas) reached agreement on criteria for evaluation. accordingly, the primary outcome is 'decision quality' 3 weeks after using the decision aid. decision quality is defined as the extent to which a patient decision aid improves the match between the chosen option and the features that matter most to the informed patient. measures include: a) patients' knowledge of essential facts \[options, benefits, harms, and outcome probabilities\]; and b. the congruence between the option chosen and patients' informed values regarding benefits and risks. in the past twenty years lung transplantation has become the most widely accepted option of treating cystic fibrosis patients with severe lung disease. lung transplantation can be a good experience for many patients, improving their quality of life and their survival. however there are potential risks of lung transplantation including infection, organ rejection and early death. cystic fibrosis patients are often faced with making a choice of whether to be referred for lung transplantation when they are very sick and there is the immediate need to survive. our group has developed a tool called a decision aid which we hope will assist the patient and family in making this choice. the decision aid guides the patient through a series of steps where they weigh the benefits and risks of being referred for lung transplantation and the benefits and risks of receiving 'usual care' without the option of referral.

patients randomized to either arm of the study will be required to undergo a lung transplantation education and counselling session with their cf physician prior to randomization. subsequent to this session patients will be randomly allocated to receive: 1) usual care plus the patient decision aid or 2) usual care. for purposes of this study, usual care will include a booklet entitled, "cystic fibrosis and lung transplantation" written by the canadian cystic fibrosis foundation plus any other written or educational material that the local cf centre normally provides.

Eligibility criteria:
inclusion criteria: * fev less than or equal to 40% predicted exclusion criteria: * patients unable to provide informed consent * patients on a lung transplant waiting list * patients who are lung transplant recipients * patients deemed too sick for transplant * only one sibling per family to minimize contamination

Keywords: cystic fibrosis, lung disease, lung transplantation, decision aid
lactulose for the prevention of nosocomial infections in children

Conditions: Nosocomial Infection

Summary: the purpose of this study is to assess the ability of lactulose, a prebiotic agent, to prevent hospital acquired infection in children

despite the adoption of norms regarding enteric isolation, nosocomial infectious diarrhea is common in children(1;2). viral pathogens, especially rotavirus are responsible for most of the cases. depending on population, type of hospital, and standard of care, the reported incidence rate ranges from 8 to 33 episodes per 100 admissions(1). infants and toddlers are at the highest risk of acquiring nosocomial viral gastroenteritis(1;2). probiotic bacteria have been shown to be beneficial in the prevention and treatment of gastrointestinal infections as well as reduction of viral shedding(3;4). a recent study by szajewska et al. (2) showed a significant reduction of nosocomial infections from 33% to 7% by prophylactic treatment with lgg during the hospital stay. another study however, did not show any difference(1). another approach is to use prebiotic treatment. prebiotics are defined as non-digestible substances that, when ingested, selectively promote the growth and establishment of beneficial probiotic-like bacteria normally present in the gut(5). lactulose is a semi-synthetic disaccharide made from lactose by a chemical reaction which was first described in 1930(6). in contrast to other prebiotics, lactulose has up to now been mainly used as a medicinal drug for constipation and hepatic encephalopathy(6). in 1957 petuely published the basic work about lactulose as "the bifidus factor" which was confirmed by macgillivray et al(6).they found that the composition of the colonic microflora of bottle-fed babies is very much like that of adults while if lactulose is added to the formula milk such babies have the same composition as breast-fed babies. lactulose has been used for 40 years in the treatment of constipation \[10\] and for more than 30 years for encephalopathy.the dosages used in pse are up to four times higher than those usually applied in constipation. no putative or definite evidence of mutagenic, genotoxic or teratogenic effects of lactulose has been obtained in human use. animal studies in rats and rabbits also did not reveal any teratogenic or reproduction-toxicologic effects, and even high dosages have had no deleterious effects(6) our hypothesis is that lactulose, with its proven prebiotic properties, given to children during their hospital stay, would be beneficial in reducing nosocomial infections.

Eligibility criteria:
inclusion criteria: * all children aged 2 to 36 months who are admitted to the hospital for reasons other than diarrhea will be eligible for the study. exclusion criteria: * children with a history of probiotics or prebiotics use within 7 days before admission, acute gastroenteritis within 3 days before admission, vomiting, treated chronic constipation, known anatomic problem in the gastrointestinal tract will be excluded from the study.

Keywords: lactulose prebiotics nosocomial infection children infants